PROJECT ABSTRACT: Manual drug compounding of chemotherapy medications permits deadly dosing errors and toxic drug exposure, posing unnecessary risks to patients and healthcare workers. Some automated drug compounding devices have been developed in response; however, poor drug containment/safety capabilities and prohibitive cost and size have limited widespread adoption of existing compounding devices. Corvida Medical has developed a working prototype for a patented, automated compounding device that will overcome the safety, cost, and size limitations of existing compounding equipment. As part of a previously funded SBIR Phase I/Phase II project, Corvida developed a disposable closed system drug transfer device (CSTD) to protect health care workers from toxic exposure to hazardous drugs used in cancer treatments. The Corvida R&D team has successfully validated and commercialized the Corvida CSTD, demonstrating its utility in the market. Preliminary data accumulated with our new automated compounding device prototype demonstrates feasibility of manipulation of components (vials, syringes and CSTD disposables), and shows accuracy and repeatability to be in the 90-95% range. Corvida now aims to further develop and validate a novel compounding device that integrates the advantages of automation technology, to enhance patient care, with the added containment/safety capabilities of a disposable CSTD, to optimize worker safety. This innovative, automated compounding-CSTD system will ensure reliable and accurate drug compounding to prevent patient medication errors and will interface with the disposable Corvida CSTD to reduce worker exposure to hazardous drugs. Further, our novel compounding device is small enough to operate within a Class II Biological safety Cabinet, so it will be available at a fraction of the cost and size of existing devices. In this Phase I project, we will demonstrate feasibility of our novel compounding equipment and validate the performance and usability of the device when integrated with the disposable Corvida CSTD. To achieve these goals, we will develop and engineer a beta prototype of the compounding device that meets preliminary specifications, functions with the Corvida CSTD, and is capable of undergoing further validation testing. We will then substantiate feasibility of the automated compounding-CSTD system through analytic validation testing for process reliability, accuracy, containment, sterility, and system throughput. We aim to show a minimum 95% reliability, 95% accuracy, containment and sterility that meet USP standards, and system throughput of at least 12 doses/hour. Successful completion of these studies will result in quantitative performance validation of an innovative, automated compounding device that works with the Corvida CSTD, providing compelling proof-of-concept to support continued development in Phase II. The resulting commercialized technology will advance current clinical practice by providing accurate and reliable compounding to ensure patients are not victims of deadly errors and will also advance occupational safety by assuring health workers are not exposed to toxic drugs.